1. Field of the Invention
The present invention relates to devices suitable for use in repairing various pelvic floor prolapse conditions. More particularly, the present invention relates to vaginal implants for such uses.
2. Background Discussion
Each year in the USA approximately 200,000 women undergo pelvic organ prolapse surgery. Pelvic organ prolapse generally involves the descent of one or more of the uterus, the bladder or the rectum along the vagina towards (or in extreme cases protruding beyond) the introitus. Women of advancing years, or those that have borne several children are more frequent sufferers of pelvic organ prolapse. Traditional vaginal surgery to address these conditions is associated with a high failure rate of between 30-40%. Complex and elaborate abdominal, vaginal and laparoscopic procedures such as abdominal sacral colpopexy, transvaginal sacrospinous ligament fixation, and laparoscopic sacral colpopexy have been developed to reduce the risk of prolapse recurrence. Unfortunately these procedures require a high level of surgical expertise and are only available to a small number of specialist practitioners and therefore to a small number of patients. Details of various procedures currently in use are described in Boyles S H., Weber A M, Meyn L. “Procedures for pelvic organ prolapse in the United States”, 1979-1997, American Journal of Obstetric Gynecology 2003, 188; 108-115.
Recently there has been a trend towards the use of reinforcing materials to support a vaginal wall damaged by prolapse. Prosthetic materials such as donor fascia lata, pig dermis and various types of synthetic mesh have been utilized with mixed success. These materials are generally positioned under the vaginal wall or walls and sutured into position.
WO 2004/045457 discloses a different approach that utilizes a prosthetic material in repairing damaged vaginal walls, and subsequently inserts an intra-vaginal splint. The splint is placed into the vagina, and operates to reduce the mobility of the vaginal walls. The repairs are typically made by dissecting either the posterior wall of the vagina, the anterior wall of the vagina, or both. A graft of either synthetic material, such as a polypropylene mesh or other fabric, or autologous or analogous material is placed in the dissected area between the vaginal wall and the prolapsing organ. The vaginal incision is then closed by suture or other tissue closure means, at which time the vaginal splint is inserted into the vagina and affixed to either wall. The splint stabilizes the vagina, keeps it elongated, and helps to hold the graft in place by preventing it from sliding or dislodging. Eventually the fascial tissue on each side of the graft will infiltrate into it thereby incorporating it into the body.
An aspect not addressed by WO 2004/045457, however, is the fact that different sized patients will require different sized splints. Simply providing the splints in numerous different sizes is not an economical solution. Co-pending U.S. patent application Ser. No. 11/258,441, which is incorporated herein by reference in its entirety, addresses this problem and provides improved implants having adjustability features, as does the present application.